Project Manager Management

[pic] [pic]

RAVI PRAKASH AGARWAL

Phone 919*********, E-mail ******@*****.***

In quest of senior managerial assignments Oracle life Science (Oracle

Clinical/AERS) Administrator/ SAS Administrator/Data Manager/ Database

Administration/ Project Management with a leading organisation.

PROFESSIONAL SYNOPSIS

An Oracle Certified Professional (OCP) and SAS Certified Base Programmer

having rich experience in Oracle Life Science, Project Planning,

Management and Implementation, Software Development, Database

Administration and team lead in the IT Sector. Currently associated with

CliniRx Research Private Limited (A J.K. Group Company) (Since 27-04-2006).

Adept in Oracle Clinical, Adverse Event Reporting Software, SAS, Developed

and worked on software for CRO including Rating Analysis Programme, CRF Log

Maintenance, Patient Dairy Maintenance and Analysis etc. Handled multiple

Clinical Studies. And handled OC/AERS/SAS Implementation and Upgradation

projects, Including License Issues. Proficient in D2K 4.5, 5, 6i, 9i,

Report 2.5, 3, 6, 9i, PL/SQL, FoxPro, Pascal and handled lots of big and

small projects. Possess exceptional communication and relationship

management skills coupled with analytical and mathematical skills.

CHIEF TASKS HANDLED ACROSS ASSIGNMENTS

TECHNICAL

Oracle Life Science: Oracle Clinical 4.5, 4.5.1, AERS

4.5

Business Intelligence Tool: SAS 9.1.3, SAS EBI,SAS EG

Programming languages: PL/SQL, BASIC, COBOL, PASCAL, C

RDBMS/DBMS: Oracle 8I, 9I, Dbase, FoxPro

DB Tools: Quest Toad

Front End: D2k 4.5, 5.0, 6.0, 9I

Complience 21 CFR Part 11, GCP,ITIL

Operating systems: Windows 9x/NT/200*-****-****, Novell

FUNCTIONAL

Administration Activities

V People Management

V Developing new policies,Developing and implementing SOP, Work Practice

etc.

V Project Planning, preparing validation Plan

V License issue (Purchase/Renewal) of OC/AERS/SAS/Oracle and other software

V Software Validation (IQ/OQ/PQ, Project Plan/Validation Plan etc.)

V Implementing CDISK, 21 CFR Part 11, GCP, ITIL

Oracle Life science

V Troubleshooting all type of problem related to OC, AERS.

V User Creation, Role Assigning, New Role creation in OC, AERS

V DE config (Data entry configuration and setting) in OC

V Discrepancy management: Creating profile, controlling roles in OC

V GLIB, Question, Question Group, Views Extract, Edit Checks, DCM,Domain

Creation, Domain management, defining Userwise/Studywise Domain in OC

V Study Locking, Freezing, Mass changes, Soft Deletion, Hard Deletion in

OC, Batch Data Loading

V Cloning of OC Database Server

V Installation/Implementation/Up-gradation of OC/AERS

V Renew/License issue of AERS/OC

V Administration of OC, AERS.

V Retrieving Data from OC and Providing as per requirement.

V TMS Loading

V Renew/License issue of WHODD/MEDDRA

V OC Customization Preparing and adding New Reports in OC/AERS as per

client requirement, those are not available in OC/AERS. These types of

reports can ease the client works. For example I can add reports in OC to

see views data, CRF data, list of patients, list of studies, study wise

patient, locked Records list, deleted/modified records list, any type of

analysis in format as client likes.

V DCF Customization. I can modify DCF report as per client requirement, for

example I can add client name/client logo in DCF, I can add additional

information like site phone no., investigator name, client phone no.

Etc. Means complete DCF can be modified /customized as per client

requirement.

V AERS Customization Preparing and adding new reports in AER, Adding new

code list on a field in entry from, modifying entry form etc.

V

Datalab

Hands on Training on Datalab In April,2011

SAS Management

V Installation/Implementation/Renewal of SAS Software

V SAS Administration using SAS BI (Business Intelligence) Server,

Enterprise Guide

V SAS connectivity with OC, Views extract etc.

V SAS Management Console (SMC) (User Creation, Library Creation, User

access, Troubleshooting, Database Connectivity, Roles on Library)

V SAS information Map studio, SAS OLAP Cube studio etc.

Software Development

V Interacting with client for requirement gathering, system study &

analysis,

V Handling various technical aspects like software design, coding of

modules, monitoring critical paths & taking appropriate actions.

V Creating test plans, test cases and test scripts/procedures for carrying

out tests of the software at various stages in the SDLC.

V Verifying change requests and defects; documenting, tracking and

communicating test plans, test results and unresolved problems; preparing

test reports.

V Overseeing the smooth implementation and testing as well as provide post-

implementation, enhancement and maintenance support to the client.

EMPLOYMENT SCAN

Clinical Studies handled at CliniRx Research Pvt. Ltd.

Project: Global, phase III study016- (2007-2009)

It was a Phase III double-blinded study of more than 670 Randomised

Patients (900 registered) in 3 countries on Parkinson's disease

Responsibility: Support and Administration of OC, SAS, AERS.

Project: Global, phase III study02 (2008)

It was a Phase III double-blinded study of 202 Randomised Patients on

Dental Pain

Responsibility: Support and Administration of OC, SAS, AERS.

Project: Global, phase III study-BL001 (in 2009)

It was a Phase III double-blinded study of 75 Randomised Patients of

schizophrenia.

Responsibility: Support and Administration of OC, SAS, AERS.

Project: Global, phase III study- Study018 (2008-2010)

It is a Phase III double-blinded study of 550 Randomised Patients in 3

countries on Parkinson's disease. It is extended study of study016.

Responsibility: Support and Administration of OC, SAS, AERS,

Implementation Projects Handled At CliniRx Research Pvt. Ltd.

Project: SAS 9.1.3 BI Server Installation (Apr, 2006)

Role: Lead Implementer and Project Manager

Responsibility: Installation and Complete Validation including IQ, OQ, PQ

Project: Oracle Clinical Installation and Data Migration (Nov, 2007 to Feb,

2008)

Role: Lead Technical Team

Responsibility: Lead technical team and perform OQ/PQ, Data Migration

Co-ordinate with installation team and help in installation

Project: Retrospective Validation of AERS and Data Migration (Jun, 2008 to

Dec, 2008)

Role: Lead Technical and Validation Team

Responsibility: Lead technical team and perform OQ/PQ, Data Migration

Co-ordinate with installation team and help in installation

Project: SAS 9.1.3 EBI Server Installation (Sep, 2009)

Role: Project Manager and Lead Validation Team

Responsibility: Manage the implementation and Validation Team

Co-ordinate with installation team, Technical

Support, Performed OQ,PQ

Project: SAS Foundation v9.1.3 Server Installation (Mar, 2010)

Role: Lead Implementer and Project Manager

Responsibility: Installation and Complete Validation including IQ,OQ,PQ

Project: AERS 4.5.0 TO 4.5.1.21 UPGRADTION (Feb 2011)

(This type of up gradation is first time in India)

Role: Lead Implementer and Project Manager

Responsibility: Installation and Complete Validation including IQ,OQ,PQ

Project: AERS 4.5.1.21 TO 4.6.2 UPGRADTION (On Going 2011)

(This type of up gradation is first time in India)

Role: Lead Implementer and Project Manager

Responsibility: Installation and Complete Validation including IQ,OQ,PQ

Software developed at CliniRx

Project: Patient Diary (Feb, 2007)

Tools: Oracle 9i/D2K 9i

Role: Project Manager /Developer

Description: This software was developed to capture the data of patient

diary for Study016 and to provide report to analyze the patient diary data.

Project: Rater List (Oct, 2007)

Tools: Oracle 9i/ D2K 9i

Role: Project Manager/Developer

Description: The project was developed to record and to prepare result of

rating score of rater's for Study016.

Project: Time Management (Jan, 2008)

Tools: Oracle 9i/ D2K 9i

Role: Project Manager/Developer

Description: This software was developed to capture the data of employees

working hours to generate invoice for client.

Project: CRF Log Management (Oct, 2008)

Tools: Oracle 9i/ D2K 9i

Role: Project Manager

Description: This software was developed to capture the data of CRF LOG.

(Like CRF received, Received by, First pass entry, second pass entry done

by, reconcile done by and reconcile done on date etc.

PREVIOUS ENGAGEMENTS

Apr'91-Apr'06 Amar Ujala Publications Limited as System

Analyst.

Aug'90 - Mar'91 Visba Exporters as EDP In charge.

Jul'90-Aug'90 Sriver Group as EDP Management Trainee.

ACADEMIC CREDENTIALS

V SAS Certified Advance Programmer for SAS 9

V Oracle Certified Professional.

V Oracle Clinical Administration training from DBMS Consulting

V PGDCA from Pupil's College, Haldwani, Nainital in 1989.

V Certificate Course in Oracle and Developer 2000 from CIStems Computers,

Bareilly in 2001.

V Certificate Course in Computer Organization and C from CIStems Computers,

Bareilly in 1999.

V M.A. (Economics) from Rohilkhand University, Bareilly in 1985

V MSc (IT) from Sikkim Manipal University in 2011.

PERSONAL DETAILS

Current Address: 679, Sector 7, Gurgaon (Haryana)

Date of Birth: 1st July 1963

Passport No. J3160670

Contact this candidate